The FDA has issued a warning letter and import alert to an Indian API manufacturer after finding major cGMP failings.
In a strongly worded and wide-ranging warning letter the US Food and Drug Administration (FDA) is critical of India-based active pharmaceutical ingredient (API) supplier Yag-Mag Labs’ Hyderabad site.
“[Inspectors observed] residues and corrosion on processing equipment; poorly identified and leaking piping; recessed ground-level floor susceptible to flooding and observed with substantial standing water; and inadequate unsanitary restroom facilities”, the FDA wrote.
After considering all these factors the FDA concluded the facility is poorly designed for cleaning and minimisation of contamination. Inspectors found no evidence non-dedicated equipment is cleaned between batches or product changeovers. Staff told inspectors no cleaning was done before April.
FDA inspectors made these observations during an inspection at the end of June. In its response Yag-Mag Labs said the facility “was not up to the mark of the FDA” and corrective actions are needed. However, the FDA wants more current good manufacturing practice (cGMP) improvements.
The FDA said: “Your firm’s broad-based cGMP compliance issues will require significant remediation and substantial investment of time and resources. We recommend that you conduct a complete and extensive evaluation of your overall quality and manufacturing controls.”
Commercial lots of finished APIs contained an unknown blend of batches making it impossible to trace products. Failings in documentation also made it difficult for inspectors to verify API quality.
Batch records were written months after manufacturing and shipping. The FDA said: “This finding that manufacturing batch records are untrustworthy represents a basic systemic failure by your company.”
Products were also manufactured from starting materials that Yag-Mag Labs failed to adequately sample. “[A starting material] had come from an unknown supplier via a distributor without product label or manufacturer information”, the FDA said.
In response to these failings the FDA has issued an import alert to stop Yag-Mag Labs’ APIs entering the US.